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NASDAQ: CEMI August 2015

NASDAQ: CEMI - SEC.gov | HOME€¦ · diagnostic solutions. ... HIV Market Syphilis Market Current Market Opportunities ... ‐ Provided DPP® Ebola Assay to CDC for Field Testing

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NASDAQ: CEMI

August 2015

Forward-Looking Statements

Statements contained herein that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of Chembio and its management. Such statements reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, Chembio’s ability to develop, manufacture, market and finance new products and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Other factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

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Our Vision & Mission

We enable longer and healthier living through detection and monitoring of serious diseases.

3

Our mission is to be a leader in the development and commercialization of diagnostic solutions. We are dedicated to delivering high-quality products that provide ease of use, and rapid and accurate results at the point-of-care (POC). As a global company, we are committed to innovation and the highest quality standards.

• Global Provider of High Quality POC Infectious Disease Tests ‐ Sales in 43 countries

• Revenue Growth Averaged 15% Over Last Five Years ‐ From $16.70MM for FY 2010; to $27.65MM for FY 2014

• Patented DPP® (Dual Path Platform) Technology ‐ Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay

(FDA-Approved, CLIA-Waived)

‐ DPP® Revenue Growth of 137% in 2014 as compared to 2013

• Future Pipeline of DPP® POC Assays ‐ DPP® HIV-Syphilis Combination Assay (US version)

‐ DPP® Fever Panel Assay (Malaria, Dengue Fever, Ebola)

• New Collaborations and Development Projects ‐ POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu

Immunostatus, Brain Injury and a Specific Type of Cancer

4

Investment Highlights

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Global POC Diagnostics Company

U.S.

• Revenue (FY ’14): $7.2MM or 28%

• Established U.S. Sales & Marketing (June ‘14)

• DPP® HIV 1/2 FDA-Approved, CLIA-Waived

• Funded Research: CDC, DOD, NIH (2013)

EUROPE

• Achieved CE mark for SURE CHECK® HIV (July ‘13)

• Achieved CE mark for HIV STAT-PAK® (March ‘14)

• Pending CE mark for DPP® HIV and DPP® HIV/Syphilis Assays

LATIN AMERICA

• Revenue (FY ‘14): $16.4MM or 63%

• Strong OEM Partnerships (e.g., FIOCRUZ, Labtest)

• Branded products sold to NGOs, private distributors

• Achieved ANVISA approval in Brazil for DPP® HIV-Syphilis Assay

ASIA

• Established License, Technical Transfer, Contract Manufacturing, Distribution Agreement (Feb. ‘14)

MERA (Middle East, Russia, Africa)

• Revenue (FY ‘14): $2.1MM or 8%

• Sales channel: NGO-direct & through distributors

• Procurements primarily funded by PEPFAR, Global Fund, and WHO

Global Professional POC Market ($ million)

POC In-Vitro Diagnostics (IVD) Total Global Market

Source: Kalorama Worldwide Market for IVD Tests - July 2012

2011 Sales 2016 Sales CAGR

Glucose 1,530 1,640 1%

Infectious Disease 810 950 3%

Critical Care 725 875 4%

Cardiac Markers 500 650 5%

Hematology 430 500 3% Coagulation/PT, ACT 400 450 2% Fecal Occult Blood 295 450 9%

Cholesterol/Lipids 275 355 5%

Drugs of Abuse 265 270 0%

HbA1c 150 300 15% Other 150 190 n/a

Pregnancy 130 135 1%

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• 35 million people were living with HIV/AIDS worldwide in 2013

• 1.6 million people died of AIDS-related illnesses in 2012

• In total, ~75 million people have been infected with the HIV virus and ~36 million have died of HIV

• Approx. 12 million people globally become ill with syphilis annually

• From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663

• Syphilis in pregnancy leads to ~305,000 fetal & neonatal deaths annually

HIV Market Syphilis Market

Current Market Opportunities

Source: World Health Organization (2012)

HIV Prevalence (15-49 years), by WHO Region New Cases of STIs, by WHO Region

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• More than 1.1 million people in the United States are living with HIV infection, and almost 1 in 6 of them (15.8%) are unaware of their infection

• There are ~50,000 new infections per year in the U.S.

• For every HIV infection that is prevented, an estimated $355,000 is saved in the cost of providing lifetime HIV treatment

HIV In The U.S. - The Importance Of Testing

Source: Center for Disease Control & Prevention (CDC) 8

Chembio “Lateral Flow" POC Tests

• Two Lateral Flow POC HIV Tests ‐ Chembio HIV 1/2 STAT-PAK®

‐ Chembio SURE CHECK® HIV 1/2 ¹

• Key Product Features ‐ FDA (PMA)-Approved, CLIA-Waived

‐ Sensitivity: 99%

‐ CE Marked, WHO-Approved

• Lateral flow patent expired in February 2015 ‐ Chembio’s royalty payment obligation for use of

lateral flow technology ended Feb 2015

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Chembio SURE CHECK® HIV 1/2*

¹ Sold in U.S. as Clearview Complete® HIV ½; sold in Europe as Chembio Stat View® HIV 1/2

Chembio HIV 1/2 STAT-PAK ®

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Mechanism Results

Screening Tests Confirmatory/Multiplex Tests

Chembio’s “Dual Path Platform” (DPP®) Technology

• Patented technology

• Allows improved sensitivity and specificity compared to lateral flow technology

• Enables multiple test results for different diseases via a single blood sample (e.g., HIV-Syphilis Combo Assay)

• Offers application within infectious disease and potential for a number of other indications

• U.S. FDA (PMA) approved, CLIA-Waived for use with blood and oral fluid samples

• U.S. Launch – Q4 2014

• Entering the ~$35MM oral fluid assay market

• Superior performance (sensitivity) vs. competitors

• Patented SampleTainer® Sample Collection System

• First to market with POC HIV-Syphilis combo assay

• First HIV-Syphilis assay to be USAID approved

• First to receive ANVISA approval (Brazil)

• Organizing clinical trials for US FDA approval.

• Successfully launched in Mexico

• Global screening opportunity: ‐ Pregnant Women (Incidence 1.9MM)1

‐ MSM (up to 70% HIV-Syphilis co-infection)2

DPP® HIV 1/2 Assay DPP® HIV-Syphilis Combo

Assay

DPP® Assays - Commercial Products

1World Health Organization (WHO); 2Center for Disease Control & Prevention (CDC) 11

DPP® Internal Development Pipeline

• DPP® HIV-Syphilis Assay (U.S. market) ‐ Next Generation DPP® HIV-Syphilis “Combo” Assay for detection of HIV and

Syphilis Antibodies

• DPP® HIV Ab/Ag Assay ‐ Next Generation DPP® HIV for the detection of HIV Antibody and Antigen

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DPP® Research Collaborations

• DPP® Malaria Assay ‐ Bill & Melinda Gates Foundation

• DPP® Dengue Fever (Multiplex Assay) ‐ Undisclosed Partner

• DPP® Ebola Multiplex Assay ‐ Integrated BioTherapeutics, Inc.

• DPP® Flu Immunostatus (Multiplex Assay) ‐ Centers for Disease Control & Prevention (CDC) Contractor

• DPP® Traumatic Brain Injury Assay ‐ Perseus Science Group, LLC

• DPP® Cancer (Specific Form) Assay ‐ Undisclosed Partner

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DPP® Technology Collaborations

• Bio-Rad Laboratories, Inc. (NYSE: BIO) ‐ DPP® Technology Used for Bio-Rad Geenius™ HIV 1/2 Confirmatory Assay

• Oswaldo Cruz Foundation (Brazil) ‐ Five DPP® Products Currently Being Sold to NGO’s and Private Distributors

• Centers for Disease Control & Prevention (CDC) ‐ Research Collaboration Agreement: DPP® Ebola and DPP® Febrile Illness

• LabTest (Brazil) ‐ Assembly, Distribution – DPP® Co-branded (2015 Product Registration)

• RVR (Malaysia) ‐ License, Technical Transfer, Contract Manufacturing, Distribution

• Other ‐ Additional Opportunities in Discussion/Development

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Chembio Manufacturing Capabilities

• Leased facilities (~60,000 sq. ft.) in Medford and Holbrook, NY

• High Volume Manufacturing Capabilities (>15MM tests annually)

• Robust Quality Management System ‐ POC tests serve diverse, regulated market

‐ Audited routinely by FDA CDRH/CBER, WHO, USDA, ISO (LNE), and our partners

‐ Expertise in manufacturing scale-up, process validation, and adherence to GMP (Good Manufacturing Processes)

• Approximately 162 employees

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Selected Financial Highlights

Six Months Ended (In 000’s) June 30, 2015 June 30, 2014

NET PRODUCT REVENUES $11,936 $12,153

TOTAL REVENUES $12,947 $13,236

GROSS MARGIN $5,706 $5,255

LOSS FROM OPERATIONS ($1,773) ($616)

NET LOSS ($1,311) ($371)

CASH (as of end of period) $1,564 $6,835

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Note: Accounts receivable as of 6/30/14 was $5,423 compared to 6/30/15 of $8,868.

• Product Development/Regulatory ‐ Achieved CE Mark for HIV 1/2 STAT-PAK®: Mar 2014

‐ Received CLIA Waiver for DPP® HIV 1/2: Oct 2014

‐ Entered development agreements for Dengue Fever and specific Cancer assay: Oct 2014

‐ Signed Agreement with CDC Contractor to Develop POC Influenza Immunity: Nov 2014

• Corporate/Operations ‐ Finalized Agreement with RVR (Malaysia) to Build Position in Asia: February 2014

‐ Established U.S. Distribution/Warehouse Facility in Holbrook, NY: May 2014

‐ Obtained Exclusive POC License for Certain IBT Ebola Reagents: Oct 2014

‐ Increased Manufacturing Footprint and Capacity in Medford, NY: Dec 2014

• Commercial / Sales & Marketing ‐ Terminated STAT-PAK® Distribution Agreement with U.S. Distributor: June 2014

‐ Established U.S. Sales & Marketing team (DPP® HIV 1/2, HIV 1/2 STAT-PAK®): June 2014

‐ Signed DPP® and STAT-PAK® agreements with 3 leading U.S. distributors: Sep-Oct 2014

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2014 Milestones - Achieved

• Product Development/Regulatory ‐ Entered into Agreement with Perseus to Develop DPP® Brain Injury Assay: January 2015

‐ Grant from Bill & Melinda Gates Foundation to Develop DPP® Malaria: January 2015

‐ Achieved ANVISA Approval for DPP® HIV-Syphilis Assay in Brazil: February 2015

‐ Provided DPP® Ebola Assay to CDC for Field Testing in West Africa: Q2 2015

‐ Initiate Clinical Trial for DPP HIV-Syphilis Assay (U.S.): anticipated Q4 2015

• Corporate/Operations ‐ Hired Paul Lambotte Ph.D. (VP, Product Development): December 2014

• Commercial / Sales & Marketing ‐ Acquired Full Rights to SURE CHECK® HIV 1/2 Assay, Effective June 1, 2016: January 2015

‐ Expand Chembio U.S. Commercialization Team: in progress during 2015

‐ Enter into Additional Distribution Agreements in the U.S. Market : in progress during 2015

‐ Launch DPP® HIV-Syphilis Assay in Brazil: anticipated Q4 2015

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2015 Milestones – Achieved & Anticipated

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Executive Leadership Team Executive Previous Experience Joined

2014

2000-2003, CFO of Visual Technology Group; 1987-2000

CFO of Protex International Corp.2003

2009-2012, Sr. VP Scientific & Laboratory Services of Pall

Corporation; 1991-2009 Pall Corporation 2012

2014

2009-2014, President of PLC Inc.; 2009-2012, Chief Science

Officer Axxin Pty Ltd.; 2000-2009, VP of R&D and Business

Development

John J. Sperzel III

President & CEO

Richard Larkin, CPA

Chief Financial Officer

Sharon Klugewicz, M.S.

Chief Operating Officer

Javan Esfandiari, M.S.

Chief Science & Technology

Officer

Thomas Ippolito

VP Regulatory & Clinical

Affairs

Michael Steele VP Sales

Marketing & Bus. Dev.

Paul Lambotte

VP Product Development

1997-2000, Co-Founder of Sinovus Biotech AB (Sweden),

acquired by Chembio in 2000; 1993-1997 R&D Director On-

Site Biotech

2000

2000-2005, VP Quality & Regulatory of Biospecific

Technologies Corp.; 1984-2000 United Biomedical Inc.,

Analytab Products Inc. and Eastern Long Island Hospital

2005

2008-2011, VP Business Development of SeraCare Life

Sciences; 1992-2008 Corautus Genetics, Life Therapeutics

and Serologicals, Inc.

2012

2011-2013, President and CEO of ITC.; 1987-2011 Axis-

Shield, Bayer Diagnostics, Instrumentation Laboratory and

Boehringer Mannheim

• Global Provider of High Quality POC Infectious Disease Tests ‐ Sales in 43 countries

• Revenue Growth Averaged 15% Over Last Five Years ‐ From $16.70MM for FY 2010; to $27.65MM for FY 2014

• Patented DPP® (Dual Path Platform) Technology ‐ Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay

(FDA-Approved, CLIA-Waived)

‐ DPP® Revenue Growth of 137% in 2014 as compared to 2013

• Future Pipeline of DPP® POC Assays ‐ DPP® HIV-Syphilis Combination Assay (US version)

‐ DPP® Fever Panel Assay (Malaria, Dengue Fever, Ebola)

• New Collaborations and Development Projects ‐ POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu

Immunostatus, Brain Injury and a Specific Type of Cancer

20

Investment Highlights